LeonaBio to Host Virtual Key Opinion Leader Event Highlighting Potential of Lasofoxifene in Treatment-Resistant ER+/HER2-, ESR1-Mutated Metastatic Breast Cancer

On April 23, 2026 LeonaBio, Inc. (NASDAQ: LONA), a clinical-stage biopharmaceutical company dedicated to the development of novel therapeutics for diseases with high unmet medical needs, reported that it will host a virtual Key Opinion Leader event with two leading physician experts in the breast cancer field to discuss the current and evolving treatment landscape in metastatic breast cancer and the potential for lasofoxifene to transform the standard of care for patients with treatment-resistant estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer.

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The event titled, "Modulation and Combination: the Potential for Lasofoxifene to Transform the Standard-of-Care in Metastatic Breast Cancer," will take place on Wednesday, April 29, 2026, beginning at 12:00 p.m. ET. To participate in the event, register here.

"As we look toward completing enrollment in ELAINE-3 later this year, with data expected in the second half of 2027, we are pleased to be joined by two leading voices in the breast cancer field to discuss the evolving treatment landscape in metastatic disease," said Mark Litton, Ph.D., President and Chief Executive Officer of LeonaBio. "This conversation will highlight the persistent gaps in care, particularly for genetically defined populations, and the potential for lasofoxifene to address a critical unmet need in patients with treatment-resistant ER+, HER2-, ESR1-mutated metastatic breast cancer."

The webcast event will feature a discussion with David Portman, M.D., Chief Executive Officer of Sermonix Pharmaceuticals and an oncology consultant to LeonaBio, along with two physician experts in the breast cancer field:

Matthew P. Goetz, M.D., Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D, Mayo Clinic, Principal investigator and director, Breast Cancer Specialized Program of Research Excellence (SPORE), Mayo Clinic Comprehensive Cancer Center and Enterprise Deputy Director, Translational Research, Mayo Clinic Comprehensive Cancer Center.
Seth Wander, M.D., Ph.D., Director of Precision Medicine, Termeer Center for Targeted Therapies, Director of Translational Research, Breast Oncology Program, Mass General Brigham Cancer Institute, Assistant Professor of Medicine, Harvard Medical School.

In addition to the live webinar, the event will be archived on the LeonaBio website under Events in the Investor Relations here.

About Metastatic Breast Cancer
Metastatic breast cancer (MBC) occurs when cancer spreads from the breast to other parts of the body—such as bones, lungs, liver, or brain. While approximately two-thirds of breast cancers are diagnosed at a localized stage, a notable proportion either present as metastatic at diagnosis or progress to that stage over time. From 2001 to 2021, approximately 4.65 million new cases of female breast cancer were reported in the United States, with approximately 260,000 (5.6%) diagnosed as distant (metastatic) stage at initial diagnosis. The metastatic breast cancer treatment market represents a sizable and rapidly expanding global opportunity with a global market of $17.1 billion in 2021, expected to expand to $41.7 billion by 2030, with a compound annual growth rate (CAGR) of approximately 10.4%. These projections reflect a market rich with innovation—from chemotherapy and hormone therapies to biologics, targeted agents and emerging personalized medicine. Growth is driven by the persistent incidence of metastatic disease, regulatory and clinical advances and evolving treatment landscapes.

About Lasofoxifene
Lasofoxifene is a novel, nonsteroidal selective estrogen receptor modulator (SERM) with a unique binding profile, designed to confer potent activity against both wild-type and mutant estrogen receptors, including the clinically significant ESR1 mutations commonly associated with resistance to endocrine therapy in metastatic breast cancer. Two Phase 2 studies—ELAINE-1 and ELAINE-2—have demonstrated its potential to address a critical unmet need in this patient population.

ELAINE-1, a randomized trial comparing lasofoxifene to fulvestrant, showed improved outcomes for lasofoxifene, including longer median progression-free survival (5.6 vs. 3.7 months), higher objective response rates (13.3% vs. 2.9%), and a durable complete response lasting more than 2.5 years. Patients also reported quality-of-life benefits and the treatment was well tolerated.

ELAINE-2, an open-label study evaluating lasofoxifene in combination with abemaciclib, demonstrated clinical benefits in heavily pretreated patients, with a median progression-free survival of approximately 13 months, an objective response rate of 56%, and a clinical benefit rate of 65.5%. The combination was generally well tolerated, with most adverse events being low grade.

Lasofoxifene is being advanced in a Phase 3 clinical trial as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The ongoing ELAINE-3 trial (NCT05696626) is evaluating lasofoxifene in combination with the CDK4/6 inhibitor, abemaciclib, and is aiming to establish a new standard of care for this genetically defined patient group.

(Press release, LeonaBio, APR 23, 2026, View Source [SID1234664739])

CatalYm Advances Visugromab into Phase 2/3 Development for Cancer Cachexia with First Patient Dosed

On April 23, 2026 CatalYm reported that the first patient has been dosed in the Phase 2/3 VINCIT trial (Visugromab IN Cachexia International Trial, NCT07112196). The global study is evaluating the company’s lead anti-GDF-15 antibody visugromab in patients with cancer-associated cachexia.

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The randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll about 518 patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors.

Cachexia is a severe metabolic condition marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance. In some types of cancer, it can affect up to 70% of patients and is responsible for 20-40% of cancer-related deaths1. Elevated GDF-15 levels are known to play a central role in the development of cachexia. Despite a high unmet medical need, there are currently no approved pharmacological treatments available.

"Cachexia remains one of the most debilitating and under-addressed complications in oncology," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers."

"The data guiding this trial show that GDF-15 is more than a bystander in cancer progression. It plays a central role in both immune resistance and metabolic decline," said Scott Clarke, Chief Executive Officer at CatalYm. "By targeting GDF-15, visugromab has the potential to open a new therapeutic path for patients whose treatment outcomes are severely impacted by cachexia."

The VINCIT trial is an adaptive Phase 2/3 study to evaluate the efficacy and safety of visugromab in reversing cachexia. In Part 1, participants are randomized to receive one of three visugromab dose levels or placebo every four weeks for 12 weeks. Based on interim analyses, a recommended dose will be selected for Part 2, which will randomize patients 2:1 to visugromab or placebo for up to 52 weeks. The trial will include clinical sites across the globe. Primary endpoints include changes in body weight and appetite over 12 weeks. Secondary endpoints assess muscle mass and function, physical activity, tumor response, overall survival, patient-reported quality of life, and safety. The study also includes exploratory pharmacodynamic and biomarker assessments.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and cachexia. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab in combination with PD-1 inhibitor nivolumab demonstrated deep and durable anti-tumor activity as well as a favorable safety profile in patients with relapsed or refractory NSCLC, hepatocellular carcinoma (HCC) and urothelial cancer (UC). The trial also provided early clinical evidence for visugromab’s potential to alleviate cancer cachexia, including meaningful weight gain in the subset of patients with moderate or severe weight loss at trial entry. These findings support visugromab’s dual potential to maintain or restore immune function and counteract cancer cachexia.

About cancer cachexia and GDF-15

Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer1. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, APR 23, 2026, View Source [SID1234664738])

Tempus and USC Announce Strategic Collaboration to Accelerate AI-Driven Precision Medicine

On April 23, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, and the Keck School of Medicine of USC and Keck Medicine of USC, reported a multi-faceted collaboration aimed at transforming patient care and accelerating research through the power of data and AI. This collaboration is designed to transform care delivery across more than 1.5 million annual patient visits to the USC Norris Comprehensive Cancer Center, the Keck Hospital of USC, USC Verdugo Hills and all USC-affiliated hospitals and clinics across Southern California.

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The collaboration is built on four foundational pillars, co-created to drive clinical impact, research scale, and long-term innovation. These include clinical testing, which enables personalized medicine by integrating Tempus’ advanced molecular diagnostics and comprehensive genomic profiling into Keck Medicine’s clinical workflows; clinical trial matching, which automates the identification of eligible patients for targeted therapies and clinical trials through Tempus’ TIME Trial Program; clinical care gap pathways, which use AI-driven insights to identify and close gaps in patient care; and research collaboration and co-development, which accelerates the translation of academic insights into validated diagnostics and therapies while jointly developing AI tools that connect research discoveries to clinical care.

"By working closely with Tempus, and in collaboration with clinical, research, and operational leaders across USC, we are aligning research, clinical care, and innovation priorities that put the patient first," said Vasiliki Anest, PhD, Chief Innovation Officer at the Keck School of Medicine of USC. "Our patient-focused commitment is to ensure discoveries and clinical innovations move thoughtfully and responsibly into practice, expanding access to personalized care and clinical trials, supporting physicians, and improving patient outcomes."

"We are tremendously excited to embark on this collaboration with USC, an institution that shares our commitment to advancing healthcare through data and technology," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "By bringing together Tempus’ AI-powered platform with USC’s world-class research and clinical expertise, we have the opportunity to create a powerful, integrated ecosystem that meaningfully transforms care delivery."

(Press release, Tempus, APR 23, 2026, View Source [SID1234664737])

Nektar Therapeutics Announces Closing of $373.8 Million Public Offering Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On April 23, 2026 Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on development of novel immunology therapies, reported the closing of its underwritten public offering of $373.8 million of shares of its common stock. Nektar sold 4,062,500 shares of common stock in the offering, which includes 529,891 shares sold upon exercise in full by the underwriters of their option to purchase additional shares of common stock in the offering. The shares of common stock were sold at a public offering price of $92.00 per share. The gross proceeds to Nektar from the offering were approximately $373.8 million, before deducting underwriting discounts and commissions and estimated offering expenses. All of the securities sold in this offering were offered by Nektar.

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Jefferies, TD Cowen, and Piper Sandler acted as joint bookrunning managers for the offering. Citigroup also acted as a bookrunner for the offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3ASR (No. 333-291466) that was filed with the U.S. Securities and Exchange Commission (the "SEC") on November 12, 2025 and automatically became effective upon filing. This offering was made only by means of a prospectus supplement and an accompanying prospectus that form a part of the registration statement.

A final prospectus supplement related to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and an accompanying prospectus related to the offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected]; Piper Sandler & Co., 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected]; or Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 (Tel: 800-831-9146).

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

(Press release, Nektar Therapeutics, APR 23, 2026, View Source [SID1234664736])

Repertoire Immune Medicines Announces First Participant Dosed in Phase 1/2 Trial of RPTR-1-201, a T Cell-Targeted Immune Medicine for Advanced Solid Tumors

On April 23, 2026 Repertoire Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, reported that the first participant has been dosed in a Phase 1/2 clinical trial of RPTR-1-201, a novel TCR bispecific therapy designed to treat advanced solid tumors. The trial is being conducted at multiple clinical sites in the United States and Europe following clearance of Repertoire’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration and authorization via the Clinical Trials Information System (CTIS) in Europe.

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"T cell-targeted immune medicines have shown they can drive deep and durable responses in some cancers, yet many patients with advanced solid tumors still have limited treatment options," said Robert Andtbacka, MD, CM, Chief Medical Officer of Repertoire. "RPTR-1-201 is designed to direct a patient’s own T cells toward a shared, tumor-selective target. Dosing the first participant is a major milestone for Repertoire and the start of evaluating RPTR-1-201’s safety and potential benefit in the clinic."

RPTR-1-201 is a TCR bispecific molecule comprised of an engineered TCR that binds with high affinity and precision to a tumor-selective epitope and an anti-CD3 moiety that engages and redirects T cells to kill tumor cells. In preclinical studies, RPTR-1-201 has demonstrated potent killing of both immunologically "hot" and "cold" tumors and a favorable preclinical safety profile. Unlike many other T cell-targeted approaches that focus on well-known antigens specific to a single tumor type, RPTR-1-201 binds to a novel epitope discovered using Repertoire’s DECODETM platform that is shared across multiple solid tumors and may be relevant for as many as 200,000 patients with metastatic or unresectable cancer each year in the U.S. and Europe.

The Phase 1/2 trial is designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose-escalation and dose-expansion phases and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody. Enrollment is ongoing at sites in the United States and Europe.

"The development of RPTR-1-201 was enabled by our platform, which identified unique TCRs against a pan-tumor, tumor-selective epitope. Subsequent TCR engineering by the Repertoire team generated an optimized TCR bispecific immune medicine that harnesses the immune system against difficult-to-treat solid tumors," said Anthony J. Coyle, PhD, President, Research and Development at Repertoire. "The initiation of this trial marks an important milestone, as RPTR-1-201 is the first validation of our ability to convert immune codes into potential immune medicines for cancer. We are both excited and humbled by the opportunity to test this drug candidate in participants with advanced cancers."

For more information about the trial, visit clinicaltrials.gov and use study identifier NCT07293754.

(Press release, Repertoire, APR 23, 2026, View Source [SID1234664735])